BridgeMD
Searching simple biomarkers to phenotype type 2 diabetic patients and personalize their treatment
EU CTIS ID: 2024-516542-19-00
What this study is testing
To assess responses to different glucose-lowering treatments - dapagliflozin vs oral semaglutide - in patients with T2D categorized into 2 groups, depending on their prevalent insulin resistance (IR) or prevalent insulin secretion deficit (ISD). The differential responses to therapy will be monitored usig a series of non-canonical (e.g., adiponectin, irisin, serpin B1) or canonical biomarkers (HbA1c, glucagon, GLP-1, GIP, insulin, proinflammatory mediators) or other metabolites potentially detected in metabo-lipidomic analysis
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Provision of informed consent prior to any study specific procedures
- Will and ability to comply with the protocol
- Age: 20 – 80 years old
- Sex: Males and Females
- Stable therapy with metformin for at least 6 months
- Suboptimal glycemic control (HbA1c ≥6.5 %)
You likely can't join if
- Previous type 1 diabetes or Late-Onset Autoimmune Diabetes of the Adult (LADA) diagnosis, as assessed by medical history
- Severe liver dysfunction
- history of pancreatitis, patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- Severe renal dysfunction (eGFR < 25 ml/min/1.73m2)
- Uncontrolled hypertension
- Uncontrolled dyslipidemia (total cholesterol > 300 mg/dl and/or LDLc > 200 and/or triglycerides > 500 mg/dl)
See the full eligibility criteria
- Provision of informed consent prior to any study specific procedures
- Will and ability to comply with the protocol
- Age: 20 – 80 years old
- Sex: Males and Females
- Stable therapy with metformin for at least 6 months
- Suboptimal glycemic control (HbA1c ≥6.5 %)
- Fasting C-peptide > 1 ng/mL (0.33 nmol/L)
- Women of childbearing potential must have a negative blood or urine pregnancy test at the baseline visit
- Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 5.9 of the protocol
- Ability to take oral medications
- Previous type 1 diabetes or Late-Onset Autoimmune Diabetes of the Adult (LADA) diagnosis, as assessed by medical history
- Severe liver dysfunction
- history of pancreatitis, patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- Severe renal dysfunction (eGFR < 25 ml/min/1.73m2)
- Uncontrolled hypertension
- Uncontrolled dyslipidemia (total cholesterol > 300 mg/dl and/or LDLc > 200 and/or triglycerides > 500 mg/dl)
- Known hypersensitivity to the active substance or to any of the excipients in study drug
- Pregnant or breast-feeding women
- Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of nonchildbearing potential
- Treatment with hormonal contraception
- Frailty in elderly participants aged > 75 years, defined as: severe comorbidities associated with limited life expectancy; or Clinical Frailty Scale (CFS) > 5; or cognitive impairment interfering with treatment adherence.
- Inability to provide informed consent
- History of diabetic ketoacidosis or hyperosmolar non ketotic coma
- Concomitant anti-diabetic drugs other than metformin
- Steroidal therapy within the last 3 months
- Medications known to significantly impact glucose metabolism (e.g., atypical antipsychotics)
- GAD-Ab positivity
- Severe obesity (BMI > 40)
- Altered levels of amylase and lipase
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.